Malawi's Option B+ programme for has led to a 763% increase in HIV-positive pregnant women receiving antiretroviral treatment (ART), according to data shown at CROI 2013.
Beth Tippet Barr presented findings from the first 18 months since the introduction of Option B+ by the Malawi Ministry of Health.
The 2010 WHO guidelines made CD4 count testing a prerequisite for PMTCT, which was unfeasible in Malawi. Instead the Department of Health expanded their ART public health programme to test-and-treat for pregnant and breastfeeding women, who are now all eligible for lifelong treatment, whatever their CD4 count or clinical stage. After a positive HIV test, women receive efavirenz/tenofovir/3TC -- this regimen will also become the standard adult first line regimen in Malawi later in 2013.
Implementation began in July 2011, which required the decentralisation of ART into all antenatal care (ANC) facilities, resulting in rapid expansion from 350 to over 650 sites. It also required training of nearly 5000 health-care workers. Prior to starting Option B+ many pregnant women still received only single dose nevirapine prophylaxis at smaller ANC sites.
A strong M&E framework underpins the programme: routine ANC and ART data is collected during quarterly supportive supervision visits, which include validation of reports from primary patient records. A 2011 independent data quality audit, commissioned by the Global Fund, showed 99.2% data accuracy.
Dr Tippett Barr presented data up to the end of 2012. Before Option B+ was introduced the initiation of ART had flat-lined in Malawi for almost two years to about 18,500 people starting per quarter. There was a rapid increase in new patients starting treatment in the first few months of the programme to almost 35,000 in the fourth quarter of 2011.
In the third and fourth quarters of 2012, the total number of women receiving any antiretrovirals during pregnancy increased to 20,687 from 13,910 in quarters one and two of 2011 -- the period preceding the implementation of Option B+. This was a 49% increase in total antiretroviral coverage of known HIV-positive pregnant women.
Such rapid scale up represents a 763% increase in the use of ART in pregnant women and the elimination of single dose nevirapine and dual prophylaxis regimens in Malawi.
An unexpected finding was the large numbers of women initiating ART during the breastfeeding period at the start of the programme -- 41% in the fourth quarter of 2011. The Department of Health had not anticipated the backlog of women who heard about Option B+ and came forward. The number of women initiating during breastfeeding was sustained at about 25% over the last two quarters of 2012.
Data on women who were already receiving ART in pregnancy were not disaggregated until the last three quarters shown in the data set, when this was about 25%. This proportion of women is expected to increase as the programme matures.
Retention in care at 12 months showed 78% of women were alive and on treatment, which was similar to 81% of all other adults. Only 4% of the Option B+ patients not retained had died, compared to 31% of other adult patients.
Several key recommendations came out of this analysis:
These data are impressive and it is amazing what programmes can achieve with political will and allocation of resources.
As pointed out in the discussion after the presentation, the retention figures are from pregnant or breastfeeding women, so there are no data yet for the plus part of Option B+. There is a strong "ART for life" message associated with the programme and It will be important to see whether women elect to remain on ART after the breastfeeding period.
The large number of women initiating ART during the breastfeeding period are concerning. This was particularly notable at the start of the programme but remained high throughout the study period. Dr Tippet Barr explained that this was community initiated -- women came in and asked for treatment -- she speculated that it was possible women had tested HIV positive previously in pregnancy but had taken time to process their diagnosis. The programme started with immediate initiation of treatment following diagnosis but now women come back to start ART after about seven days.
Monitoring the programme will include birth defect surveillance.
Barr BT et al. Uptake and retention in Malawi's Option B+ PMTCT program: lifelong ART for all HIV+ pregnant or lactating women. 14th CROI. Atlanta, GA. 3-6 March 2013. Oral abstract 82.
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